Neuroprotection with phenytoin in optic neuritis
What it found
We found no results in the registry or in papers.
What was tested
Treatment tested
- Phenytoin
Sodium channel alpha subunit blocker
What it measured
Main measures
The primary outcome measure is the thickness of the retinal nerve fibre layer (RNFL). The sample size of 45 participants per arm provides a power of 80% to detect a treatment effect of 50% at 5% significance level (two-tailed), comparing mean follow-up affected eye RNFL adjusted for baseline unaffected eye RNFL (a conventional ANCOVA adjusting for baseline affected eye RNFL is avoided because of a
Retina scans (OCT)Bladder, bowel and sexual function
Other measures (1)
1. Does phenytoin improve visual outcome? This represents a secondary endpoint in the present study, since the inbuilt redundancy of the nervous system suggests that it will be more difficult to demonstrate an effect of treatment on visual function than on atrophy. For this first clinical study atrophy has therefore been chosen as a more sensitive surrogate marker to be the primary endpoint, but
Brain volume lossVision
Who could take part
Optic neuritis
Inclusion: a) A clinical diagnosis of acute unilateral optic neuritis (with or without a prior diagnosis of MS), with a visual acuity of ≤ 6/9 (20/30) and an interval between onset of visual loss and randomization of ≤ 14 days. Exclusion: a) Any co-morbid ocular disease or previous history of optic neuritis in either eye, as this would interfere with the assessment of outcome.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
In optic neuritis, there is inflammation of the optic nerve, which carries visual information from the eye into the brain. People with optic neuritis lose vision in the eye affected by the disorder, and vision may not recover fully.
Papers
Loading reviews and guidelines…
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History
Started
Aug 2011
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